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Data / Medical devices / Powered Laser Surgical Instrument / Israel

FDA-registered makers of Powered Laser Surgical Instrument in Israel: 22 establishments

22 establishments in Israel are registered with the FDA to make Powered Laser Surgical Instrument (product code GEX). 11 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in IsraelWatch these makers
Device
Powered Laser Surgical Instrument
Product code
GEX
Country
Israel

Makers of Powered Laser Surgical Instrument in Israel

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Alma Lasers Ltd.CAESAREA Northern, IsraelForeign private label distributor, Manufacturer29September 24, 2025000api.fda.gov
Lumenis Be LtdYokneam, Ha Zafon 2069236 Haifa, IsraelManufacturer, Specification developer9April 16, 2025000api.fda.gov
Lumenis, Ltd.YOKNEAM Northern, IsraelManufacturer, Specification developer8May 18, 2026050api.fda.gov
Inmode Ltd.Yokneam Northern, IsraelManufacturer6June 26, 2025000api.fda.gov
Viora Ltd.Migdal HaEmek Northern, IsraelComplaint file establishment, Exporter to the US, Manufacturer4November 18, 2016000api.fda.gov
Formatk Systems Ltd.Tirat Hacarmel Northern, IsraelManufacturer3December 11, 2018000api.fda.gov
Sharplight Technologies Ltd.RISHON LEZION Tel Aviv, IsraelManufacturer3December 22, 2023000api.fda.gov
Active Optical Systems, Ltd./Efraim BidasPETACH-TIKVA Central, IsraelManufacturer2February 12, 2016000api.fda.gov
G.N.S Neolaser Ltd.Caesarea Central, IsraelComplaint file establishment, Manufacturer2March 13, 2025000api.fda.gov
LIGHT INSTRUMENTS Ltd.Yokneam Northern, IsraelComplaint file establishment, Exporter to the US, Manufacturer, Specification developer2March 23, 2010000api.fda.gov
Endymed Medical LtdCaesarea Northern, IsraelManufacturer1October 7, 2022000api.fda.gov
Atena (from The Imco Group) LtdNesher Haifa, IsraelContract manufacturer0000api.fda.gov
B.Y. Medimor LtdTiberias Northern, IsraelContract manufacturer0000api.fda.gov
Biometrix Ltd.Jerusalem, IsraelContract manufacturer0000api.fda.gov
Gevasol TechnologiesBeit Shean Northern, IsraelContract manufacturer0000api.fda.gov
Gti Medical LtdNetanya Central, IsraelContract manufacturer0000api.fda.gov
Itamar MedicalCAESAREA Haifa, IsraelManufacturer0000api.fda.gov
Itamar Medical Ltd. (Alon)Caesarea Haifa, IsraelManufacturer0000api.fda.gov
K.P. Impulse Group International Ltd.Rishon Le Zion Central, IsraelContract manufacturer0000api.fda.gov
R.H. Electronics Ltd.Nof Hagalil Northern, IsraelContract manufacturer0000api.fda.gov
Tamuz F.T.K. SolutionsAfula Northern, IsraelContract manufacturer0000api.fda.gov
Usr Electronic Systems (1987) LtdKarmiel Northern, IsraelContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.